Submission for Office of Management and Budget (OMB) Review; Culture of Continuous Learning Project: Case Study of a Breakthrough Series Collaborative for Improving Child Care and Head Start Quality (New Collection), 77123-77125 [2022-27241]
Download as PDF
<![CDATA[
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Notices
lotter on DSK11XQN23PROD with NOTICES1
II. Advisory Committee Membership
Roster
On November 23, 2021, HHS
published a Notice of Charter and
Invitation for Member Nominations in
the Federal Register for the GAPB
Advisory Committee (86 FR 66565
through 66566). HHS received a total of
52 complete member nominations from
the public by December 13, 2021. The
nominees were evaluated by the
Departments for alignment with the
membership categories required under
Section 117 of the No Surprises Act,
their professional qualifications,
recognition by the ground ambulance
and emergency medical services
community, years of relevant
experience, experience with State or
Federal committees on related issues,
and expertise in subject matter to be
addressed by the committee. The
Departments also considered
membership balance as required by
FACA, and as appropriate to address
health equity issues pertaining to
ground ambulance consumer balance
billing, and ground ambulance services
in underserved communities.
The 17 Members of the GAPB
Advisory Committee are:
• Asbel Montes—Committee
Chairperson; Additional
Representative determined necessary
and appropriate by the Secretaries
• Ali Khawar—Secretary of Labor’s
Designee
• Thomas West—Secretary of
Treasury’s Designee
• Rogelyn McLean—Secretary of Health
and Human Services’ Designee
• Gamunu Wijetunge—Department of
Transportation—National Highway
Traffic Safety Administration
• Suzanne Prentiss—State Insurance
Regulators
• Adam Beck—Health Insurance
Providers
• Patricia Kelmar—Consumer Advocacy
Groups
• Gary Wingrove—Patient Advocacy
Groups
• Ayobami Ogunsola—State and Local
Governments
• Ritu Sahni—Physician specializing in
emergency, trauma, cardiac, or stroke
• Peter Lawrence—State Emergency
Medical Services Officials
• Shawn Baird—Emergency Medical
Technicians, Paramedics, and Other
Emergency Medical Services
Personnel
• Edward Van Horne—Representative
of Various Segments of the Ground
Ambulance Industry
• Regina Godette-Crawford—
Representative of Various Segments of
the Ground Ambulance Industry
VerDate Sep<11>2014
20:05 Dec 15, 2022
Jkt 259001
• Rhonda Holden—Representative of
Various Segments of the Ground
Ambulance Industry
• Loren Adler—Additional
Representative determined necessary
and appropriate by the Secretaries
The GAPB Committee Roster will also
be posted on the GAPB website at:
https://www.cms.gov/regulationsguidance/advisory-committees/
advisory-committee-ground-ambulanceand-patient-billing-gapb.
III. Meeting Agenda
The first meeting of the GAPB
Advisory Committee will occur on
January 17 and 18, 2023. During this
meeting, the Committee will gather
background information on the No
Surprises Act, the ground ambulance
industry, insurance and billing
practices, and consumer issues such as
disclosure of fees and balance billing,
prior to discussing potential
subcommittees and focus areas. The
agenda will cover the following topics:
• No Surprises Act overview
• Overview of the ground ambulance
industry
• Insurance and ground ambulance
payment systems
• Ground ambulance billing practices
• Disclosure of charges to consumers,
separation of charges and cost shifting
• Impact of balance billing on
consumers and current consumer
protections
• Balance billing prevention, including
potential legislative and regulatory
options
A more detailed agenda and materials
will be made available approximately 2
days before the meeting on the GAPB
website (listed above).
IV. Public Participation
This meeting will be open to the
public. Attendance may be limited due
to virtual meeting constraints. Interested
parties are encouraged to register as far
in advance of the meeting as possible.
To register for the meeting, please visit:
https://www.cms.gov/regulationsguidance/advisory-committees/
advisory-committee-ground-ambulanceand-patient-billing-gapb. CMS is
committed to providing equal access to
this meeting for all participants and to
ensuring Section 508 compliance.
Closed captioning will be provided. If
you need alternative formats or services
because of a disability, such as sign
language interpreter or other ancillary
aids, please contact the person listed in
the FOR FURTHER INFORMATION CONTACT
section.
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
77123
V. Submitting Written Comments
Members of the public may submit
written comments on subject matter
under committee deliberation prior to
the webinar via email to
gapbadvisorycommittee@cms.hhs.gov.
Comments must be submitted via email
no later than January 3, 2023. During the
virtual meeting, members of the public
will have the opportunity to submit
comments through the chat feature of
the webinar platform. These comments
will be compiled for future
consideration by the committee.
V. Viewing Documents
You may view the documents
discussed in this notice at https://
www.cms.gov/regulations-guidance/
advisory-committees/advisorycommittee-ground-ambulance-andpatient-billing-gapb.
The Administrator of CMS, Chiquita
Brooks-LaSure, having reviewed and
approved this document, authorizes
Lynette Wilson, who is the Federal
Register Liaison, to electronically sign
this document for purposes of
publication in the Federal Register.
Dated: December 12, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2022–27263 Filed 12–13–22; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for Office of Management
and Budget (OMB) Review; Culture of
Continuous Learning Project: Case
Study of a Breakthrough Series
Collaborative for Improving Child Care
and Head Start Quality (New
Collection)
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, Department of
Health and Human Services.
ACTION: Request for public comments.
AGENCY:
The Office of Planning,
Research, and Evaluation (OPRE),
Administration for Child and Families
(ACF) is proposing an information
collection activity for the Culture of
Continuous Learning Project (CCL). The
goal of the project is to assess the
feasibility of implementing continuous
quality improvement methods in early
care and education (ECE) programs and
systems to support the use and
SUMMARY:
E:\FR\FM\16DEN1.SGM
16DEN1
77124
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Notices
sustainability of evidence-based
practices.
DATES: Comments due within 30 days of
publication. OMB must make a decision
about the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. You can also obtain
copies of the proposed collection of
information by emailing
OPREinfocollection@acf.hhs.gov.
Identify all emailed requests should be
identified by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: The CCL project is
proposing a new information collection
activity to assess the feasibility of
implementing continuous quality
improvement methods in ECE programs
and systems to support the use and
sustainability of evidence-based
practices. Three Breakthrough Series
Collaboratives (BSCs), a specific quality
improvement model designed to
support the implementation of
continuous quality improvement
methods in organizations, will be
implemented in Head Start and child
care settings. The BSC methodology has
been studied extensively in health care
and other fields but has limited
evidence as an effective quality
improvement methodology in the early
childhood field. The findings will be of
broad interest to ECE programs as well
as training and technical assistance
providers and researchers, all of whom
are interested in improving the quality
of services young children receive.
Head Start and child care programs
that voluntarily participate in the BSCs
will be asked to complete a number of
tools designed to facilitate
implementation of the BSC. The
implementation of the BSCs will be
evaluated using a case study design that
will involve focus groups, interviews,
surveys, and classroom observations. To
fully capture participants’ experiences
in the BSCs, the implementation and
evaluation instruments are designed to
engage respondents one to three times
during a thirty six-month period,
depending on the instrument. The goal
of the case study is to document the
factors that contribute to the feasibility
of BSC implementation within a state
quality improvement system (e.g., a
state quality rating and improvement
system) and/or a regional professional
development or technical assistance
system (e.g., a region within a state, or
a cross-state region such as Head Start
regional technical assistance areas) such
that we can refine hypotheses and study
measures which will be useful in the
design of an evaluation for a future
study of BSCs in ECE systems. The case
study will also help determine what
additional capacity ECE systems may
need to adopt the BSC methodology and
offer it within their system at a larger
scale.
Respondents: Up to 45 ECE programs
will be invited to complete an
application to participate in a BSC and
up to five people per program will be
involved in completing the application.
Up to eight programs will be selected to
participate in one of three BSCs, for a
total of up to 24 programs. Within each
program, up to seven individuals (e.g.,
directors, lead teachers, assistant
teachers, teacher aides, parents,
curriculum specialists, etc.) will
participate in the implementation of the
BSC, meaning that up to 168 individuals
will participate. Respondents will also
include additional teachers (up to 114),
program staff (up to 96), and parents (up
to 2,136) located at participating Head
Start and child care programs where a
BSC is implemented but who are not
members of the BSC Team.
ANNUAL BURDEN ESTIMATES
Number of
respondents
(total over
request period)
Instrument
Number of
responses per
respondent
(total over
request period)
Avg. burden
per response
(in hours)
Total burden
(in hours)
Annual burden
(in hours)
BSC Implementation Instruments
Instrument 1: BSC Selection Application Questionnaire ..........................................................................
Instrument 2: Pre-Work Assignment: Data Collection
Planning Worksheet .................................................
Instrument 3: Plan, Do, Study, Act (PDSA)Form &
Tracker .....................................................................
Instrument 4: Monthly Metrics .....................................
Instrument 5: Implementation Discussion Forum
Prompts ....................................................................
Instrument 6: Learning Session Feedback Form ........
Instrument 7: Action Planning Form ............................
Instrument 8: BSC Overall Feedback Form ................
Instrument 9: Organizational Self-Assessment ...........
225
1
1.5
338
113
48
1
2
96
32
168
48
34
8
0.25
1.5
1,428
576
476
192
168
168
168
168
168
34
4
4
1
5
0.25
0.25
0.25
0.25
1.5
1,428
168
168
42
1,260
476
56
56
14
420
9
1
1
9
3
30
2
1.5
90
30
30
1
0.17
5
2
24
2
1
48
16
lotter on DSK11XQN23PROD with NOTICES1
BSC Evaluation Instruments
Instrument 10: Key Informant Interviews with BSC
Faculty Members Affiliated with the States/Regions
Discussion Guide .....................................................
Instrument 11: BSC Implementation Staff and Faculty
Focus Group Discussion Guide ...............................
Instrument 12: BSC Implementation Staff and Faculty
Background Survey ..................................................
Instrument 13: Key Informant Interviews with BSC
Center Administrators Discussion Guide .................
VerDate Sep<11>2014
20:05 Dec 15, 2022
Jkt 259001
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
E:\FR\FM\16DEN1.SGM
16DEN1
77125
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Instrument
Instrument 14: BSC Teachers and Support Staff
Focus Group Discussion Guide ...............................
Instrument 15: BSC Parent Focus Group Discussion
Guide ........................................................................
Instrument 16: Individual BSC Teams Focus Group
Discussion Guide .....................................................
Instrument 17a: Administrator Surveys .......................
Instrument 17b: Teacher Surveys ...............................
Instrument 17c: Other Center Staff Surveys ...............
Instrument 17di: Non-BSC Parent Surveys .................
Instrument 17dii: BSC Parent Surveys ........................
Instrument 18: Classroom Observations .....................
Instrument 19: Administrative Data Survey .................
Estimated Total Annual Burden
Hours: 2,770.
Authority: Head Start Act 640 [42
U.S.C. 9835] and 649 [42 U.S.C. 9844];
appropriated by the Continuing
Appropriations Act of 2019. Child Care
and Development Block Grant Act of
1990 as amended by the CCDBG Act of
2014 (Public Law 113186).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–27241 Filed 12–15–22; 8:45 am]
BILLING CODE 4184–22–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0710]
Circumstances That Constitute
Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection;
Draft Guidance for Industry, Revision
1; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
lotter on DSK11XQN23PROD with NOTICES1
20:05 Dec 15, 2022
Jkt 259001
Annual burden
(in hours)
1.5
360
120
24
2
1.5
72
24
168
24
240
96
2136
24
48
24
2
3
3
3
2
3
3
4
1.5
0.5
0.5
0.5
0.25
0.5
0.33
0.25
504
36
360
144
1068
36
48
24
168
12
120
48
356
12
16
8
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
Frm 00069
Total burden
(in hours)
2
inspection. This draft guidance
describes, for both drugs and now
devices, the types of behaviors (actions,
inactions, and circumstances) that the
FDA considers to constitute delaying,
denying, or limiting inspection, or
refusing to permit entry or inspection.
Once finalized, this draft guidance is
intended to supersede the October 2014
FDA final guidance for industry
entitled, ‘‘Circumstances that Constitute
Delaying, Denying, Limiting, or
Refusing a Drug Inspection.’’ However,
until this draft guidance is finalized, the
October 2014 FDA guidance remains in
effect until it is withdrawn and will
continue to reflect FDA’s current
thinking on this issue. FDA is
particularly interested in comments on
the inclusion of devices to the October
2014 guidance.
DATES: Submit either electronic or
written comments on the draft guidance
by February 14, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
PO 00000
Avg. burden
per response
(in hours)
120
Electronic Submissions
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance entitled, ‘‘Circumstances that
Constitute Delaying, Denying, Limiting,
or Refusing a Drug or Device
Inspection.’’ The FDA Reauthorization
Act of 2017 (FDARA) amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) so that, as is the case with
a drug, a device is deemed to be
adulterated if the owner, operator, or
agent of the factory, warehouse, or
establishment at which the device is
manufactured, processed, packed, or
held delays, denies, or limits an FDA
SUMMARY:
VerDate Sep<11>2014
Number of
responses per
respondent
(total over
request period)
Number of
respondents
(total over
request period)
Fmt 4703
Sfmt 4703
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–D–0710 for ‘‘Circumstances that
Constitute Delaying, Denying, Limiting,
or Refusing a Drug or Device
Inspection.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
E:\FR\FM\16DEN1.SGM
16DEN1
]]>Agencies
[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Notices]
[Pages 77123-77125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27241]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for Office of Management and Budget (OMB) Review;
Culture of Continuous Learning Project: Case Study of a Breakthrough
Series Collaborative for Improving Child Care and Head Start Quality
(New Collection)
AGENCY: Office of Planning, Research, and Evaluation, Administration
for Children and Families, Department of Health and Human Services.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Office of Planning, Research, and Evaluation (OPRE),
Administration for Child and Families (ACF) is proposing an information
collection activity for the Culture of Continuous Learning Project
(CCL). The goal of the project is to assess the feasibility of
implementing continuous quality improvement methods in early care and
education (ECE) programs and systems to support the use and
[[Page 77124]]
sustainability of evidence-based practices.
DATES: Comments due within 30 days of publication. OMB must make a
decision about the collection of information between 30 and 60 days
after publication of this document in the Federal Register. Therefore,
a comment is best assured of having its full effect if OMB receives it
within 30 days of publication.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. You can
also obtain copies of the proposed collection of information by
emailing [email protected]. Identify all emailed requests
should be identified by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The CCL project is proposing a new information
collection activity to assess the feasibility of implementing
continuous quality improvement methods in ECE programs and systems to
support the use and sustainability of evidence-based practices. Three
Breakthrough Series Collaboratives (BSCs), a specific quality
improvement model designed to support the implementation of continuous
quality improvement methods in organizations, will be implemented in
Head Start and child care settings. The BSC methodology has been
studied extensively in health care and other fields but has limited
evidence as an effective quality improvement methodology in the early
childhood field. The findings will be of broad interest to ECE programs
as well as training and technical assistance providers and researchers,
all of whom are interested in improving the quality of services young
children receive.
Head Start and child care programs that voluntarily participate in
the BSCs will be asked to complete a number of tools designed to
facilitate implementation of the BSC. The implementation of the BSCs
will be evaluated using a case study design that will involve focus
groups, interviews, surveys, and classroom observations. To fully
capture participants' experiences in the BSCs, the implementation and
evaluation instruments are designed to engage respondents one to three
times during a thirty six-month period, depending on the instrument.
The goal of the case study is to document the factors that contribute
to the feasibility of BSC implementation within a state quality
improvement system (e.g., a state quality rating and improvement
system) and/or a regional professional development or technical
assistance system (e.g., a region within a state, or a cross-state
region such as Head Start regional technical assistance areas) such
that we can refine hypotheses and study measures which will be useful
in the design of an evaluation for a future study of BSCs in ECE
systems. The case study will also help determine what additional
capacity ECE systems may need to adopt the BSC methodology and offer it
within their system at a larger scale.
Respondents: Up to 45 ECE programs will be invited to complete an
application to participate in a BSC and up to five people per program
will be involved in completing the application. Up to eight programs
will be selected to participate in one of three BSCs, for a total of up
to 24 programs. Within each program, up to seven individuals (e.g.,
directors, lead teachers, assistant teachers, teacher aides, parents,
curriculum specialists, etc.) will participate in the implementation of
the BSC, meaning that up to 168 individuals will participate.
Respondents will also include additional teachers (up to 114), program
staff (up to 96), and parents (up to 2,136) located at participating
Head Start and child care programs where a BSC is implemented but who
are not members of the BSC Team.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per Avg. burden
Instrument respondents respondent per response Total burden Annual burden
(total over (total over (in hours) (in hours) (in hours)
request period) request period)
----------------------------------------------------------------------------------------------------------------
BSC Implementation Instruments
----------------------------------------------------------------------------------------------------------------
Instrument 1: BSC Selection 225 1 1.5 338 113
Application Questionnaire..
Instrument 2: Pre-Work 48 1 2 96 32
Assignment: Data Collection
Planning Worksheet.........
Instrument 3: Plan, Do, 168 34 0.25 1,428 476
Study, Act (PDSA)Form &
Tracker....................
Instrument 4: Monthly 48 8 1.5 576 192
Metrics....................
Instrument 5: Implementation 168 34 0.25 1,428 476
Discussion Forum Prompts...
Instrument 6: Learning 168 4 0.25 168 56
Session Feedback Form......
Instrument 7: Action 168 4 0.25 168 56
Planning Form..............
Instrument 8: BSC Overall 168 1 0.25 42 14
Feedback Form..............
Instrument 9: Organizational 168 5 1.5 1,260 420
Self-Assessment............
----------------------------------------------------------------------------------------------------------------
BSC Evaluation Instruments
----------------------------------------------------------------------------------------------------------------
Instrument 10: Key Informant 9 1 1 9 3
Interviews with BSC Faculty
Members Affiliated with the
States/Regions Discussion
Guide......................
Instrument 11: BSC 30 2 1.5 90 30
Implementation Staff and
Faculty Focus Group
Discussion Guide...........
Instrument 12: BSC 30 1 0.17 5 2
Implementation Staff and
Faculty Background Survey..
Instrument 13: Key Informant 24 2 1 48 16
Interviews with BSC Center
Administrators Discussion
Guide......................
[[Page 77125]]
Instrument 14: BSC Teachers 120 2 1.5 360 120
and Support Staff Focus
Group Discussion Guide.....
Instrument 15: BSC Parent 24 2 1.5 72 24
Focus Group Discussion
Guide......................
Instrument 16: Individual 168 2 1.5 504 168
BSC Teams Focus Group
Discussion Guide...........
Instrument 17a: 24 3 0.5 36 12
Administrator Surveys......
Instrument 17b: Teacher 240 3 0.5 360 120
Surveys....................
Instrument 17c: Other Center 96 3 0.5 144 48
Staff Surveys..............
Instrument 17di: Non-BSC 2136 2 0.25 1068 356
Parent Surveys.............
Instrument 17dii: BSC Parent 24 3 0.5 36 12
Surveys....................
Instrument 18: Classroom 48 3 0.33 48 16
Observations...............
Instrument 19: 24 4 0.25 24 8
Administrative Data Survey.
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 2,770.
Authority: Head Start Act 640 [42 U.S.C. 9835] and 649 [42 U.S.C.
9844]; appropriated by the Continuing Appropriations Act of 2019. Child
Care and Development Block Grant Act of 1990 as amended by the CCDBG
Act of 2014 (Public Law 113186).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022-27241 Filed 12-15-22; 8:45 am]
BILLING CODE 4184-22-P
